SHINE: Trends and Satisfaction in Hypertensives Using Aktiia Optical BP Monitoring Device (SHINE)

NCT06356077 | Completed

• 1 other identifier: SHINE
• Study Type: observational
• Target: 1,729
• Locations: 1 country
• Sites: 1

Brief Summary

The SHINE study aims to gather data on the evolution of participant's blood pressure and to correlate this with demographic, lifestyle and health factors in a hypertensive population as well as, to gather data on participants' perception of the device under test (Aktiia 24/7).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure evolution over 12 weeks

  Means, medians, standard deviations, and ranges for Blood Pressure readings and changes in Blood Pressure readings within the study population between week 1 to week 12.

  3 months

Secondary Outcomes (2)

• Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor

  3 months

• Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors.

  3 months

Study Arms (1)

Study cohort

Each study subject will receive an Aktiia device and will use it continuously for 3 months. Study participants will have to complete 2 different surveys: one at baseline, and one after the 3 months of Aktiia device use to give their perception on the Aktiia device use as compared to other blood pressure monitors currently on the market.

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The final study population should cover the following phenotypes: * Close to 50% females and 50% males, * At least 20% of non-Caucasian participants, * At least 20% of participants with Systolic Blood Pressure (SBP) ≥150mmHg (assessed at baseline via the study device).

You may qualify if:

• Adult participants aged 22 to 85 years old
• A participant whose last blood pressure reading was within the last 12 months and was either:
• SBP ≥145
• or ≥DBP 90
• People who use either an iOS or Android smartphone
• People who have 2 arms
• Able and willing to provide informed consent and to adhere to study procedures.

You may not qualify if:

• Participants whose BP data submitted is \>180 mm Hg systolic OR \>120 mm Hg diastolic .
• Participants with a self-reported known diagnosis of
• atrial fibrillation
• congestive heart failure
• heart valve disease
• pheochromocytoma
• Raynaud's disease
• arm lymphedema
• Participants who take insulin
• Participants who are on hemodialysis
• Women who are self-reported to be pregnant
• Participants whose arms shake uncontrollably or are paralyzed (cannot move)
• Participants with upper arm circumference \<22 cm or \>42 cm
• Participants with wrist circumference \>23cm
• Participation in another interventional clinical study or use of investigational drugs in the last 30 days.

Sponsors & Collaborators

• Aktiia SA: lead
• Lindus Health: collaborator

Study Sites (1)

Lindus Health

London, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 10, 2024
• Study Start: July 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

GB (1)